Unique Pharmaceutical, Ltd.
Form 483 issued April 2, 2014 · Temple, Texas
- Inspection
- Mar 17 – Apr 2, 2014
- Investigator
- J. Christopher
- Observations
- 10
- Pages
- 7
- FEI number
- 3002468086
In short: On April 2, 2014, FDA issued a Form 483 with 10 observations to Unique Pharmaceutical, Ltd. in Temple, Texas (FEI 3002468086) after an inspection that ran Mar 17 – Apr 2, 2014. The investigator was J. Christopher. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Production errors are not…
- 04
Clothing of personnel engaged in the processing of drug products is not appropriate for…
This inspection in context
J. Christopher
1 document · 2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmUnique Pharmaceutical, Ltd. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unique Pharmaceutical, Ltd.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Unique Pharmaceutical, Ltd.?
J. Christopher is named on this Form 483, for the inspection of Mar 17 – Apr 2, 2014. Each investigator has a profile showing what they cite most.
When was Unique Pharmaceutical, Ltd. inspected by FDA?
The inspection ran Mar 17 – Apr 2, 2014, and the Form 483 is dated April 2, 2014.
How do I get the full Form 483 for Unique Pharmaceutical, Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.